Regulatory and Legal
Members of Congress Introduce Legislation To Close Loophole In Medical Device Approval Process
Feb 03, 2012
Reps. Edward J. Markey (D-Mass.), Henry A. Waxman (D-Calif.), Jan Schakowsky (D-Ill.), and Rosa DeLauro (D-Conn.) announced in a press release that they have...
Senators Introduce Legislation to Remove Regulations Slowing Innovation for Medical Device Manufacturers
Feb 03, 2012
Senators Bob Casey (D-PA) and John McCain (R-AZ) announced in a press release that they have introduced legislation to remove burdensome regulations that hurt...
IRS Moves Forward with Plans to Implement Medical Device Tax
Feb 03, 2012
The IRS has recently released proposed regulations to implement the 2.3% medical device tax, which has been cast by critics as a "tongue depressor...
Senators Welcome FDA Medical Device User Fee Agreement
Feb 02, 2012
Senators Tom Harkin (D-IA) and Mike Enzi (R-WY), the Chairman and Ranking Member of the Senate Committee on Health, Education, Labor and Pensions (HELP),...
FDA, Medical Device Industry Reach Agreement in Principle on Medical Device User Fees
Feb 01, 2012
FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a...
FDA Releases 2012 Medical Device Priorities
Jan 31, 2012
FDA's Center for Devices & Radiological Health has announced its strategic medical device priorities for 2012. The device center said it will focus on the...
CDRH Ombudsman Reports on Complaints
Jan 30, 2012
The ombudsman of FDA's Center for Devices and Radiological Health reported that it had 461 contacts with the public in 2011, up 11% from the previous year....
What You Should Know about Patent Reform: The Post-Grant Review Process
Jan 22, 2012
MD+DI: Could you explain the post-grant patent review process?   David Dykeman is a patent attorney and co-chair of the IP department at...
Newt Gingrich Wants to Whip FDA into Shape
Jan 20, 2012
  If you missed Newt Gingrich's response to John King last night, check it out on You Tube. This morning everyone was talking about Newt Gingrich...
Blog: Can Obama Survive a Second Round of Healthcare Reform?
Jan 19, 2012
Last week, The Global Leaders conducted the 2nd Annual Healthcare Forum and Networking Reception with the express design of bringing innovators (medtech,...